AlloGen-LI Treatment of Spinal Stenosis

Status Withdrawn

Clinical Trial Summary

In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal stenosis and/or disc herniation. The patients will be followed for 12 weeks. The effect of this treatment will be examined by patient reported changes in pain and disability utilizing validated outcome measures, and MRI imaging evaluating changes in contrast enhancement and T2 signal related to that reflect inflammation and degeneration.

Clinical Trial Description

AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of osteorarthritis and degenerative disc disease. Anti-inflammatory components include inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues, including amniotic fluid, amniotic membrane and chorion are regulated as human cell and tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft materials for human injection. AlloGen-LI is derived from placental tissues obtained from carefully screened healthy mothers at the time of scheduled cesarean section. The mothers have agreed to donate the tissues, which would otherwise be discarded. The experimental treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural space under CT guidance, in an identical manner to traditional epidural steroid /marcaine injections. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02932020
Study type	Interventional
Source	University of Southern California
Contact
Status	Withdrawn
Phase	N/A
Start date	October 2016
Completion date	September 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03916705` - Thoraco-Lumbar Fascia Mobility	N/A
Completed	`NCT04007302` - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago	N/A
Completed	`NCT03273114` - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain	N/A
Recruiting	`NCT03600207` - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain	N/A
Completed	`NCT04284982` - Periodized Resistance Training for Persistent Non-specific Low Back Pain	N/A
Recruiting	`NCT05600543` - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain	N/A
Withdrawn	`NCT05410366` - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed	`NCT03673436` - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed	`NCT02546466` - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain	N/A
Completed	`NCT00983385` - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics	Phase 3
Recruiting	`NCT05156242` - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain.	N/A
Recruiting	`NCT04673773` - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.	N/A
Completed	`NCT06049277` - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain	N/A
Completed	`NCT06049251` - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises	N/A
Completed	`NCT04980469` - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle	N/A
Completed	`NCT04055545` - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects	N/A
Recruiting	`NCT05944354` - Wearable Spine Health System for Military Readiness
Recruiting	`NCT05552248` - Assessment of the Safety and Performance of a Lumbar Belt
Completed	`NCT05801588` - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life	N/A
Completed	`NCT05811143` - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.